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Pulmonary Arterial HypertensionPhase 2NCT04483115

Acute Haemodynamic Study of TPN171H in Patients with Pulmonary Arterial Hypertension

A Phase 2 study testing TPN171H and Tadalafil in people with Pulmonary Arterial Hypertension, run by Vigonvita Life Sciences at 9 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a phase IIa proof-of-concept study to evaluate the effect of single-dose TPN171H tablets on acute haemodynamic parameters in patients with pulmonary arterial hypertension.The trial is expected to include 60 patients, divided into 6 groups, according to 1:1:1:1:1:1 into the placebo group and the test… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
TPN171H and Tadalafil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
9 sitesChina
Study dates
16 Nov 2020to 29 Jun 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18 to 75;
  • Patients who have voluntarily decided to participate in this study, and signed the informed consent form;
  • Patients who are able to understand and follow study plans and instructions;
  • Patients with symtomatic PAH (Group1), a pulmonary vascular resistance (PVR) > 3 Wood, a mean pulmonary artery pressure (mPVP) ≥25 mmHg and a pulmonary artery wedge pressure (PAWP) ≤ 15 mmHg either due to:
  • Idiopathic PAH (IPAH)
  • Familial PAH
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  • Associated PAH due to drugs or toxins
  • Associated PAH due to connective tissue disease
  • Associated PAH due to congenital heart disease, if patients underwent surgical correction more than 1 year prior to screening
  • Have a current diagnosis of being in WHO functional class II or III;
  • Patients who are willing to take proper contraceptive during the study and within 3 months after the study completed.

Who cannot join

  • All types of PH except subtypes of Group1 specified in the inclusion criteria;
  • Moderate to severe COPD (FEV1 < 60% predicted);
  • Moderate to severe restrictive lung disease (FVC < 70% predicted);
  • Pre-treatment with PAH therapy within the last 1 months before the screening visit (including endothelin receptor antagonists, PDE5 inhibitors, guanylate cyclase agonist and prostacycline analogues);
  • A "positive" response to acute vasodilator testing;
  • Coagulation dysfunction (defined as activated partial thromboplastin time and international normalized ratio are both >1.5 times upper limit normal) or patients with potential bleeding risk;
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  • Hepatic dysfunction indicated by: serum bilirubin>3 times upper limit normal, ALT and AST>2.5 times upper limit normal;
  • Renal insufficiency (creatinine clearance<30 mL/min)；
  • Systolic blood pressure<90 mmHg at screening;
  • QT prolongation at screening, whose values (QTcF) exceeding 450 msec in males and 470 msec in females;
  • Have enrolled in/or have a plan of an exercise training program for pulmonary rehabilitation before the screening visit/or during the study;
  • Patients who have a recent (within 3 months) history of abusing alcohol or illicit drugs;
  • Body weight<40 kg；
  • Patients who have participated in a clinical study involving another investigational drug within 1 month before the screening visit;
  • For any other reasons that affect compliance with the study protocol, especially the long-term monitoring of floating catheters, according to the decision of investigators;
  • HBV, HCV, HIV or Tp infection;
  • Patients with gastrointestinal, urinary, reproductive, immunologic, endocrine, or central nervous system disease that, in the opinion of the investigator, will affect the study;
  • Have a history of malignancies within 2 years, except for a cured basal cell or skin squamous cell carcinoma;
  • Pregnant women, or breast feeding women;
  • Patients with hypersensitivity to iloprost or any of the excipients.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

China9 sites

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100032

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Fuwai Hospital CAMS&PUMC

    Beijing, Beijing Municipality, 100037

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

  • First Affiliated Hospital Of Gannan Medical University

    Ganzhou, Jiangxi, 341000

  • Gansu Provincial Hospital

    Lanzhou, Gansu, 730000

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: Multi-center, Randomized，Placebo and Positive Controlled Clinical Study of TPN171H Tablets on Acute Haemodynamics in Patients with Pulmonary Arterial Hypertension

This study is a phase IIa proof-of-concept study to evaluate the effect of single-dose TPN171H tablets on acute haemodynamic parameters in patients with pulmonary arterial hypertension.The trial is expected to include 60 patients, divided into 6 groups, according to 1:1:1:1:1:1 into the placebo group and the test drugs 2.5mg, 5mg, 10mg group, tadalafil tablets 20mg, 40mg group, each group 10 cases.

Read the detailed description

This study is a multi-center, randomized, placebo and positive controlled phase IIa proof-of-concept study to evaluate the effect of single-dose TPN171H tablets on acute hemodynamic parameters in patients with pulmonary arterial hypertension.The trial is expected to include 60 patients, divided into 6 groups, according to 1:1:1:1:1:1 into the placebo group and the test drugs 2.5mg, 5mg, 10mg group, tadalafil tablets 20mg, 40mg group, each group 10 cases. During the screening period, the tube placement period, and the observation period, the patients will conduct various inspections and evaluation observations as required.

The Swan-Ganz floating catheter and echocardiography were used to evaluate the efficacy of TPN171H; PK parameters: including Tmax, Cmax, AUC0-t , t1/2,CL/F, Vz/F, λz; Safety evaluation indicators include: vital signs, physical examination, laboratory examination (blood routine, blood biochemistry, blood gas analysis), 12-lead ECG, adverse events.

Being tested
TPN171H, Placebo, Tadalafil
Keywords
pulmonary arterial hypertension, Acute Haemodynamic Study, PK/PD study, TPN171H, Simmerafil
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TPN171HDrug

    Also called Simmerafil

    Tablets; Oral; Single dose

  • PlaceboDrug

    Tablets; Oral; Single dose

  • TadalafilDrug

    Also called ADCIRCA

    Tablets; Oral; Single dose

Study groups in NCT04483115
Study groupRoleWhat they receive
TPN171H 2.5mg groupExperimentalTPN171H 2.5mg tablet + Placebo 10mg tablet
Receives: Drug: TPN171H
TPN171H 5mg groupExperimentalTPN171H 5mg tablet + Placebo 10mg tablet
Receives: Drug: TPN171H
TPN171H 10mg groupExperimentalTPN171H 10mg tablet + Placebo 5mg tablet
Receives: Drug: TPN171H
Placebo groupPlacebo comparatorPlacebo 5mg tablet+ Placebo 10mg tablet
Receives: Drug: Placebo
tadalafil 20mg groupActive comparatortadalafil tablet 20mg
Receives: Drug: Tadalafil
tadalafil 40mg groupActive comparatortadalafil tablets 20mg *2
Receives: Drug: Tadalafil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of the maximum change in pulmonary vascular resistance(PVR) to the second baseline

    Measured: Within 24 hours after drug administration

Secondary outcomes (4)

  1. Time of maximum change in PVR

    Measured: Within 24 hours after drug administration

  2. The area under the curve for reduction in PVR

    Measured: Within 24 hours after drug administration

  3. Change in arterial oxygenation

    Measured: Within 24 hours after drug administration

  4. Change in right ventricular function

    Measured: Within 24 hours after drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2020
  2. Study start16 Nov 2020
  3. Primary completion29 Jun 2022
  4. Study completion29 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04483115
Sponsor's protocol ID
TPN171H-P201
Status last verified
Dec 2021
First submitted
15 Jul 2020
Last updated
24 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TPN171H and Tadalafil in people with Pulmonary Arterial Hypertension, run by Vigonvita Life Sciences at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of the maximum change in pulmonary vascular resistance(PVR) to the second baseline (time frame: Within 24 hours after drug administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04483115.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.

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